Method, apparatus and catheter for positioning terminal end of pacemaker lead, which has passed through coronary sinus, in interventricular septum

ABSTRACT

The present invention relates to a method for positioning a tip of a pacemaker lead that has passed through coronary sinus into an interventricular septum. More particularly, it relates to a method for positioning a tip of a pacemaker lead that has passed through a coronary sinus into an interventricular septum in order to more effectively transmit an electrical stimulus in a treatment using a pacemaker for patients with arrhythmia. 
     A method of positioning a tip of a pacemaker lead, which has passed through a coronary sinus, into an interventricular septum, in order to effectively transmit electrical stimulus, includes: inserting into an intervention wire through a superior vena cava and a coronary sinus to pass through the interventricular septum and then guiding the intervention wire to an inferior vena cava; and positioning the tip of the lead into the interventricular septum by inserting the pacemaker lead along the intervention wire.

TECHNICAL FIELD

The present invention relates to a method, an apparatus, and a catheterfor positioning a tip of a pacemaker lead that has passed throughcoronary sinus into an interventricular septum. More particularly, itrelates to a method, an apparatus, and a catheter for positioning a tipof a pacemaker lead that has passed through a coronary sinus into aninterventricular septum in order to more effectively transmit anelectrical stimulus in a treatment using a pacemaker for patients witharrhythmia.

BACKGROUND ART

Since a pacemaker was first introduced by Furman and Rovinson in 1958,the pacemaker has been used as an important device for treating patientswith bradyarrhythmia. Recently, a pacemaker is usually used intreatments for arrhythmia such as complete atrioventricular block, highdegree atrioventricular block, and sinus node dysfunction accompanied bysymptoms. A treatment using a pacemaker is a method that artificiallyprovides an electrical stimulus when an electrical stimulus is notnormally transmitted to a heart.

FIG. 1 is a view of a conduction system of a heart, in which (A) shows aflow in a conduction system, (B) shows a waveform in anelectrocardiogram, and (C) illustrates the relationship between aconduction process and a waveform.

Referring to FIG. 1, according to the conduction of the heart, anelectrical stimulus is transmitted to the overall ventricles through aconduction pathway after passing through a sinoatrial (SA) node, anatrioventricular (AV) node in atriums and then passing through thebundle of His and a bundle branch in ventricles. Transmission ofstimulus in a ventricle is made by a His-Purkinje system.

In an electrocardiogram, a QRS-complex is generated by a depolarizationprocess of ventricular muscles, the first downward wave following aP-wave is called a Q-wave, the first upward wave is called an R-wave,and the downward wave following the R-wave is called an S-wave. Thewidth of the QRS means the time taken for electricity to be conductedthroughout the entire ventricles. The width of the QRS is within about0.12 seconds (around about 90 ms) in a normal state, but when it is 0.12seconds or more, it indicates the presence of an interventricularconduction defect including blocks.

A pacemaker is composed of a generator and a lead. The generatorsupplies power and includes a computer, so it supplies power, ifnecessary, or suspends the power by checking the state of electricityflowing into a heart through the lead. The lead transmits electricityfrom the generator to the heart.

FIG. 2 shows the treatment performed at present by a pacemaker.

According to a common treatment that is performed by a pacemaker atpresent, the tip of the lead of a pacemaker is inserted and fixed in theapex of the right ventricle (RV apex) of ventricles and then electricalstimulus is provided. This is called right ventricular apical pacing(RVAP).

As for RVAP, the electrical stimulus at the RV apex is not transmittedthrough the conduction system that is a special tissue structure forquickly transmitting electrical stimulus in a ventricle, but transmittedthrough cariomyocytes of the ventricle that relatively slowly transmitelectrical stimulus, so it takes long time for the electrical stimulusto spread through the entire ventricle. It means that the QRS widthincreases in an electrocardiogram and is called “Wide QRS”. That is, theQRS passing through the RVAP is about 160 ms, which is considerablydelayed as compared with 90 ms for a normal case.

The Wide QRS causes non-uniformity of motion of ventricles, that is,ventricular desynchronization, so it causes a side effect of loss of theventricular function. Many studies for obtaining narrower QRS by givingelectrical stimulus to portions close to a conduction system at aninterventricular septum have been conducted to overcome the side effect.

Representatively, a method of positioning the tip of a pacemaker lead ata right ventricular basal septum and applying electrical stimulus aroundthe conduction system has been attempted. This is called rightventricular septal pacing (RVSP). The RVSP is most usually used at theinterventricular septum of a right ventricular outflow tract (RVOT).

The RVSP theoretically compensates for the defects of the RVAP, but inthe actual operation it is difficult to accurately position the lead ofa pacemaker at the interventricular septum around the RVOT and the leadmay be separated or moved, so the operation itself is difficult andaccordingly it is not generally used. The RVSP has anothercharacteristic that positions the lead tip at an interventricularseptum, but stimulates not the inside, but the outer side of theinterventricular septum, and it is known that the RVSP is less effectivethan the method of stimulating the endocardium or the center of aninterventricular septum.

Another method of obtaining a narrower QRS is applied to a case when apatient with heart failure accompanied by ventricular insufficiency hasa wide QRS in an electrocardiogram. This method uses two leads, andpositions a lead at an RV apex and applies electrical stimulus andpositions the other lead at a left lateral vein and applies electricalstimulus to a side of the left ventricle. That is, it is a treatment forsecuring a narrower QRS by simultaneously applying electrical stimulusto the RV apex and the side of the left ventricle. It is called “CardiacResynchronization Therapy (CRT)”.

The CRT is known as a very effective and remarkable treatment when apatient with heart failure has LBBB (left bundle branch block), etc.However, the CRT has a defect that it has to use two leads forstimulating ventricles in order to obtain a narrower QRS.

According to the treatments used up to now, if it possible to directlyapply electrical stimulus to the interventricular septum where theconduction system of ventricles are positioned when applying electricalstimulus to the ventricles, it is possible to obtain a narrower QRS andthe transmission direction of the electrical stimulus can applybiological electrical stimulus, so it is possible to overcome theproblems with the RVAP and expect good effects from some patients whoneed CRT.

According to various recent studies on animals, it has been reportedthat it is possible to further compensate for the defects of the RVAP bydirectly applying electrical stimulus to the interventricular septum andit is also possible to give help for ventricular insufficiency thatneeds the CRT. Intraseptal pacing that can apply direct electricalstimulus to an interventricular septum has been attempted, and methodsby forcibly positioning the lead of a pacemaker into theinterventricular septum directly through the left ventricle from theright ventricle have been disclosed in US2010/0298841 and US2013/0231728. These methods have high invasion depth that causes anartificial loss of interventricular septum between the left and rightventricles, have a high possibility of tearing surrounding tissuesduring the operation, and have a high possibility of causing an embolismdue to air or blood clots. Further, the methods have many dangers andlimits, for example, it can locally approach the middle portion or theapex of ventricles rather than the base which is preferable.

Accordingly, it is required to study a method that can more safely andsimply obtain a narrower QRS by directly applying electrical stimulus tothe conduction system of a ventricle.

DISCLOSURE Technical Problem

In order to solve the problems, an object of the present invention is toprovide a method, an apparatus, and a catheter for applying directelectrical stimulus to an interventricular septum, where the conductionsystem of the heart is positioned, and more safely and simplypositioning the tip of a pacemaker lead passing through a coronary sinusinto the interventricular septum in order to more effectively applyelectrical stimulus in a treatment using a pacemaker.

In detail, an object of the present invention is to provide a method, anapparatus, and a catheter for applying direct electrical stimulus to aninterventricular septum, where the conduction system of the heart ispositioned, and more safely and simply positioning the tip of apacemaker lead passing through a coronary sinus into theinterventricular septum without safety problems, thereby overcomingdefects of wide QRS pacing due to RVAP of the related art, removingdifficulty in an operation that is a defect of the RVAP, improving a wayof applying electrical stimulus, and achieving treatment effect withonly one lead without using two leads that is a defect of CRT.

Technical Solution

In order to achieve the objects of the present invention, a method ofpositioning a tip of a pacemaker lead, which has passed through acoronary sinus, into an interventricular septum, in order to effectivelytransmit electrical stimulus, includes: inserting into a interventionwire through a superior vena cava and a coronary sinus to pass throughthe interventricular septum and then guiding the intervention wire to aninferior vena cava; and positioning the tip of the lead into theinterventricular septum by inserting the pacemaker lead along theintervention wire.

According to an embodiment of the present invention, an apparatus forpositioning a tip of a pacemaker lead, which has passed through acoronary sinus, into an interventricular septum where a conductionsystem of a heart is positioned, in order to effectively transmitelectrical stimulus, includes: a intervention wire connected through ainferior vena cava, a coronary sinus, an interventricular sinus, a rightventricle, and an inferior vena cava; a surgical catheter passingthrough the inferior vena cava and a safe zone to capture theintervention wire positioned in the right ventricle; and a pacemakerlead inserted along the intervention wire such that the tip ispositioned in interventricular septum tissues.

The apparatus further includes a balloon-tipped guiding catheter havinga hole therein for passing the intervention wire and having a balloonthat is formed at a front end to be inflated by air from the outside sothat a septal vein positioned at the interventricular septum is easilyfound by blocking the coronary sinus.

Advantageous Effects

As described above, according to the method of positioning the tip of apacemaker lead passing through a coronary sinus into an interventricularseptum, the pacemaker lead is positioned into the interventricularseptum using a septal vein on the basis of the coronary sinus and thenelectrical stimulus is applied. Accordingly, it is possible to (1)overcome the defects of wider QRS pacing due to RVAP of the related artand (2) expect treatment effect with only one lead without using twoleads for patients to whom narrower QRS can be applied only with septalpacing of patients who need CRT of the related art.

Further, according to the present invention, as in the method disclosedin US 2010/0298841 A1 and US 2013/0231728 A1, it is possible to minimizethe danger of an operation by positioning the lead of a pacemakerthrough a relatively simple operation in a vein, using a path that ismaximally naturally formed along an interventricular septum withoutusing a high-dangerous and non-physiological operation that artificiallyopen a left ventricle for high-pressure arteries and a right ventricleunder low pressure.

DESCRIPTION OF DRAWINGS

FIG. 1 is a view of a conduction system of a heart, in which (A) shows aflow in a conduction system, (B) shows a waveform in anelectrocardiogram, and (C) illustrates the relationship between aconduction process and a waveform.

FIG. 2 shows the treatment performed at present by a pacemaker.

FIG. 3 is a flowchart illustrating a method of positioning the tip of apacemaker lead, which as passed through a coronary sinus, into aninterventricular septum, in accordance with an embodiment of the presentinvention.

FIG. 4 is a schematic diagram illustrating the method of positioning thetip of a pacemaker lead, which as passed through a coronary sinus, intoan interventricular septum, in accordance with an embodiment of thepresent invention.

FIG. 5 is a picture of a pressurized septal venogram when a coronarysinus is blocked by a balloon catheter according to an embodiment of thepresent invention.

FIG. 6 is a schematic cross-sectional view of a dual lumen catheteraccording to an embodiment of the present invention, in which (A) showsthe case when the first tube and the second tube have the same lengthand (B) shows the case when the first tube and the second tube havedifferent lengths.

FIGS. 7 and 8 are partial cut views of a heart for showing a process ofboring the interventricular septum using a dual lumen catheter accordingto an embodiment of the present invention, in which FIG. 7 shows thecase when the advancing direction of a support wire is an RVIT directionand FIG. 8 shows the case when the advancing direction of the supportwire is an RV epicardial vein direction.

FIG. 9 is a view showing a process of boring the interventricular septumusing a needle type lumen catheter according to an embodiment of thepresent invention.

FIGS. 10 and 11 are anatomical pictures showing actual examples of asafe zone and an unsafe zone that a guide wire of the present inventionpasses through.

FIG. 12 shows an example of a safe zone catheter having a balloon andFIG. 13 shows an example of a safe zone catheter having a pigtail-shaped blocking member.

FIG. 14 is a view illustrating a process of capturing a interventionwire using a mesh of a capture catheter of the present invention.

FIG. 15 is a view showing another example of a mesh that is disposed atan end of a capture catheter of the present invention.

FIG. 16 is a view showing another example of a surgical catheter of thepreset invention, in which a balloon is formed at the front (top) endand a mesh is formed under the balloon.

FIG. 17 is a picture showing a capture catheter having a D-shaped meshas another example of a capture catheter of the present invention, inwhich (a) shows the state before the mesh expands and (b) shows thestate after the mesh expands.

FIG. 18 is a picture when the mesh of a capture catheter captures aintervention wire passing through an interventricular septum inaccordance with an embodiment of the present invention.

FIG. 19A is a picture showing a tip of a pacemaker lead inserted intissues of an interventricular septum in accordance with an embodimentof the present invention and FIG. 19B is a picture showing a pacemakerlead according to CS based intraseptal pacing of the present inventionand a pacemaker lead positioned at an RV apex according to an RVAP ofthe related art.

FIG. 20(A) shows natural QRS fluctuations in a pig used in a test, FIG.20(B) shows QRS fluctuation according to Intra-septal pacing accordingto the present invention, and FIG. 20(C) shows QRS fluctuationsaccording to RVAP of the related art.

BEST MODE

The present invention relates to a method, an apparatus, and a catheterthat positions a tip of a pacemaker lead into an interventricular septumafter passing the tip through a coronary sinus in order to moreeffectively transmit electrical stimulus in a treatment using apacemaker. That is, the method and apparatus position the tip of apacemaker lead into an interventricular septum to directly applyelectrical stimulus to an interventricular septum where the conductionsystem of the heart is positioned.

The RVSP described above positions the tip of a pacemaker lead on theouter side of the interventricular septum rather than the inside, so itis less effective in terms of transmitting electrical stimulus in aninterventricular septum when theoretically transmitting electricalstimulus to the conduction system in the interventricular septum.

The inventor(s) has developed a method and an apparatus that canposition the tip of a pacemaker lead using a wire that passes through asuperior vena cava, a coronary sinus, and an inferior vena cava.

A method of positioning the tip of a pacemaker lead of the presentinvention includes: i) positioning a intervention wire inserted througha superior vena cava and a coronary sinus (CS) into the right ventricleof the heart through an interventricular septum; ii) inserting asurgical catheter inserted in an inferior vena cava into the rightventricle through the right atrium and a safe zone of the tricuspidvalve and then capturing the intervention wire using a capturing unit ofthe surgical catheter; iii) pulling out the surgical catheter toward theinferior vena cava and pulling out the intervention wire captured by thesurgical catheter toward the interior vena cava; and iv) positioning thetip of the lead into the interventricular septum by holding both ends ofthe intervention wire and inserting the lead of the pacemaker along theintervention wire. In other words, the method largely includes: passinga intervention wire through an interventricular septum after passing itthrough a superior vena cava and a coronial sinus and then guiding theintervention wire to an inferior vena cava; and positioning the tip of alead into the interventricular septum by inserting the lead of thepacemaker along the intervention wire.

A method of positioning a tip of a pacemaker lead into aninterventricular septum of the present invention will be describedhereafter in more detail with the accompanying drawings.

FIG. 3 is a flowchart illustrating a method of positioning the tip of apacemaker lead into an interventricular septum in accordance with anembodiment of the present invention and FIG. 4 is a schematic diagramillustrating a method of positioning the tip of a pacemaker that haspassed through a coronial sinus into an interventricular septum.

Referring to FIGS. 3 and 4, i) a step (S10) of positioning aintervention wire inserted through a superior vena cava and a coronarysinus SC into the right ventricle of the heart through aninterventricular septum is shown.

The intervention wire (intervention wire) is inserted through thesuperior vena cava and the coronary sinus and guided into the inferiorvena cava through the interventricular septum, and then the upper andlower portions are fixed by a surgeon, thereby supporting a pacemakerlead such that the pacemaker lead is inserted through the coronary sinusand inserted into the interventricular septum. Preferably, theintervention wire is a intervention wire of about 0.014″. Theintervention wire guides the pacemaker lead, so it is also called apacemaker lead guide wire.

The intervention wire is moved into the interventricular septum througha septal vein that is an appropriate ventricular base. However, it isgenerally difficult for a surgeon to recognize the septal vein.Accordingly, there is a need for a balloon-tipped guiding catheterhaving a hole therein for passing a intervention wire. Theballoon-tipped guiding catheter, which is a catheter having a balloon atthe front (top) end, blocks a coronary sinus by expanding the balloon byinjecting air from the outside after being inserted through a superiorvena cava and the coronary sinus. Accordingly, the blood current in thecoronary sinus is blocked, whereby the pressure in the coronary sinusincreases and the coronary sinus expands. Thereafter, the septal vein inthe interventricular septum is found by projecting a pressurizedvenogram. The intervention wire is passed through the interventricularseptum by external force after being inserted into the septal veinthrough the hole of the balloon-tipped guiding catheter.

FIG. 5 is a picture of a pressurized septal venogram when a coronarysinus is blocked by a balloon catheter according to an embodiment of thepresent invention. In detail, FIG. 5 is a picture obtained in thefollowing embodiment.

After the intervention wire passes through the interventricular septum,the balloon-tipped guiding catheter is removed outside and the tip ofthe intervention wire is positioned in the ventricle.

On the other hand, when the septal vein is not seen or is short, or itis difficult to bore the interventricular septum through the septalvein, a specific interventricular septum lumen catheter is required. Theinterventricular septum lumen catheter may be a dual lumen catheterhaving two tubes for inserting two wires and a needle type lumencatheter using a needle.

That is, in general, it is possible to directly bore an interventricularseptum with a intervention wire without a specific interventricularseptum lumen catheter by pointing the tip of the intervention wire, butan interventricular septum lumen catheter is required in the exceptionalcase described above.

First, the dual lumen catheter may be used when it is not preferable tobore an interventricular septum after passing a intervention wirethrough a septal vein.

FIG. 6 is a schematic cross-sectional view of a dual lumen catheteraccording to an embodiment of the present invention, in which (A) showsthe case when the first tube and the second tube have the same lengthand (B) shows the case when the first tube and the second tube havedifferent lengths, and FIGS. 7 and 8 are partial cut view of a heart forshowing a process of boring an interventricular septum using a duallumen catheter according to an embodiment of the present invention, inwhich FIG. 7 shows the case when the advancing direction of a supportwire is an RVIT direction and FIG. 8 shows the case when the advancingdirection of the support wire is an RV epicardial vein direction.

Referring to FIG. 6, the dual lumen catheter is composed of a first tubein which a support wire is inserted and a second tube in which aintervention wire is inserted. The first tube 11 and the second tube 12of the lumen catheter is fixed in contact with each other, in which twotubes may be in contact with each other or one tube may be divided intotwo spaces by a film. The first tube 11 and the second tube 12 may bethe same or different in length. FIG. 6A shows the case when the firsttube and the second tube have the same length and FIG. 6B shows the casewhen the first tube and the second tube have different lengths. When itis not required to make the support wire longer than the interventionwire, the first tube and the second tube are made different in length bymaking the first tube shorter as in FIG. 6B.

The support wire 21 inserted in the first tube 11 supports theintervention wire 22 inserted in the second tube 12 when theintervention wire 22 bores an interventricular septum, that is,functions as a support that prevents the intervention wire 22 from beingpushed back when the intervention wire 22 bores an interventricularseptum. The intervention wire 22, as described above, is connected to aninferior vena cava after passing through the interventricular septum,thereby guiding or supporting a pacemaker lead that is inserted later.

Since the support wire functions as a support and the intervention wirepasses through the interventricular septum, the support wire may besofter than the intervention wire in many cases.

The lumen catheter has a radiopaque marker 14. The radiopaque marker 14is provided to help the intervention wire bore an interventricularseptum by finding the location of the lumen catheter through a display.That is, the radiopaque marker 14 is provided for easy boring of aninterventricular septum.

Meanwhile, an inclined guide 14 having a predetermined angle is formedat the second tube tip, that is, the exit of the second tube of thelumen catheter. This is for the intervention wire 22 to be able to borean interventricular septum through the second tube 12.

Referring to FIGS. 7 and 8 to explain the process of boring, the lumencatheter is inserted into a coronary sinus and then the support wire 21is inserted into the first tube 11 of the lumen catheter. Alternatively,the support wire may be inserted first and then the lumen catheter isinserted, or the lumen catheter may be inserted with the support wireinserted therein.

In general, the support wire 21 is moved along various paths, dependingon the characteristics of the wire and the shape of the septal vein, forexample, in a right ventricular inflow tract (RVIT) direction inaccordance with the connection direction of the coronary sinus. Theintervention wire may be easily taken out of the preferable exit of theright ventricle such as the RVIT without help of other devices (otherwires or other catheters), but is not guided to the preferable exit inmany cases. That is, the ideal wire exits are different for eachpatient. When it is difficult to bore an interventricular septum onlywith a intervention wire, the operation becomes easy by using a supportwire, so a dual lumen catheter is useful in this case.

The support wire 21 is inserted, and then the lumen catheter is moved toan appropriated position in an interventricular septum and theintervention wire 22 is inserted into the second tube 12 of the lumencatheter. It is possible to find the location where the interventionwire comes out, that is, the location of the tip of the second tubethrough the radiopaque marker 14 and the location is the“interventricular septum-through start point”.

It is possible for a surgeon to relatively easily find whether thesupport wire has been inserted in the right ventricular inflow tract(RVIT) (septal vein) direction or the RV epicardial vein direction bychecking the shape of the heart, the positions of blood vessels, and thepositions of the wires while performing an angiogram. Accordingly, thesurgeon can find the location of the support wire and bores theinterventricular septum by pushing the intervention wire, as shown inFIGS. 7 and 8.

The intervention wire that has passed through the interventricularseptum is guided to the right ventricle. Preferably, the tip of theintervention wire is pointed or made of a hard material to easily borethe interventricular septum. Accordingly, the intervention wire isguided to the right ventricle and then the lumen catheter and thesupport wire are removed.

A needle lumen catheter that is another type of lumen catheter using aneedle can be used when the septal vein of an interventricular septum isnot easily found even by contrast.

FIG. 9 is a view showing a process of boring an interventricular septumusing a needle lumen catheter according to an embodiment of the presentinvention.

Referring to FIG. 9, a need lumen catheter is used to bore aninterventricular septum using a intervention wire. The needle lumencatheter, which is used to connect an end of a coronary sinus (CS) andthe right ventricle to each other by moving through a superior vena cavaand a coronary sinus (CS) and then boring the interventricular septumthat is the membrane between the coronary sinus (CS) and the rightventricle, is largely composed of a body 110, a needle 120, and afixture 130.

The body 110 is a hollow tube and has a hole 112 for the needle at anend thereof.

The needle 120 is inserted in the body 110 and can movedforward/backward through the hole 111. The hole 111 is moved to aportion to be bored by inserting the catheter is through a superior venacava and a coronary sinus and then the needle 120 is moved forward,thereby boring the interventricular septum. The front end of the needle120 is pointed to be quickly bore the interventricular septum withoutdamaging surrounding tissues. An operation unit for operating the needle120 at the outside may be further provided to bore the interventricularseptum by moving the needle 120 forward/backward.

The fixture 130 is provided to prevent other portions except the portionto be bored from being bored or the needle 120 from being pushedbackward such that the portion is not bored at a time when the needle120 moves forward to bores the interventricular septum. For thispurpose, the fixture 130 is positioned to correspond to the hole 111 andthen the needle 120 is moved forward, thereby boring theinterventricular septum. The fixture 130, in this process, supports thebody 110 to prevent the body 110 from being pushed backward.

The fixture 130 may be a balloon that can be inflated by air from theoutside, so a pump for injecting air into the balloon from the outsideto inflate the balloon may be further provided. When a balloon is usedas the fixture 130, it is possible to adjust the air pressure withoutdamaging the coronary sinus (CS) even if the balloon touches the innerside of the coronary sinus.

Meanwhile, an injection unit that can inject a contrast medium into theballoon may be further provided so that the boring position of theinterventricular septum can be seen. Since a contrast agent is insertedinto the balloon, it is possible to estimate the location of the hole111 corresponding to the balloon, so it is possible to visually checkthe boring position and the position to which the needle 120 is moved.

A method of guiding/inserting the intervention wire into the rightventricle using a needle lumen catheter is described with reference toFIG. 9. First, as in (a) of FIG. 9, a needle lumen catheter 100 is movedclose to a desired boring position along the coronary sinus (CS).Thereafter, the boring position and the hole 111 are aligned and thenfixed by the fixture 130 not to move from the position. The fixture 130may be a balloon. In other words, air is injected into the balloon withthe boring position and the hole 111 aligned.

Accordingly, as in (b) of FIG. 9, the balloon pushes the inner side ofthe coronary sinus (CS) so that the body is fixed in contact with theboring position. Therefore, it is possible to prevent the boringposition from being changed by the body 110 pushed backward when theneedle 120 moves forward and bores the boring position later. Further,it is possible to visually find whether the hole 111 is at the accurateposition with respect to the boring position when injecting air into theballoon or by injecting a contrast medium later.

After these steps, as in FIG. 9c , the needle 120 is moved in the bodyand bores the interventricular septum through the hole 111. Thereafter,the intervention wire is inserted and guided to the right ventricle.

There may be many methods of inserting the intervention wire afterboring the interventricular septum with the needle. First, there is amethod of inserting only the intervention wire after taking the lumencatheter out of the body and then guiding the intervention wire into theright ventricle through the bored portion of the interventricularseptum. Second, there is a method of moving the needle 120 backwardafter boring, moving the intervention wire through the body 110, andthen guiding it into the right ventricle. Third, there is a method ofguiding the front end of the needle 120 into the right ventricle bymoving the intervention wire into the needle 120 after boring theinterventricular septum by moving the needle 120 forward. The thirdmethod needs a hole at the end of the needle 120 through which theintervention wire can move and the hole is required not to influence theneedle boring the interventricular septum.

The lumen catheters (dual lumen catheter and the needle lumen catheter)may be individually used, but may be used as a balloon-tipped guidingcatheter by forming a balloon at the front end. When a balloon iscoupled to the front end, as described above, it can block the coronarysinus, so the septal vein can be contrasted well.

Next, ii) a step (S20) of inserting the catheter inserted in theinferior vena cava into the right ventricle through the right atrium andthe safe zone of the tricuspid valve and then capturing the interventionwire with the capturing unit of the catheter is performed. In this step,there is a need for a safe zone catheter that is supposed to safely passthrough the safe zone and a capture catheter that captures theintervention wire guided in the right ventricle in the step i).

When the safe zone catheter and the capture catheter are different, thestep ii) is, in detail, composed of a step of inserting the safe zonecatheter inserted in the inferior vena cava into the right ventriclethrough the right atrium and the safe zone of the tricuspid valve, astep of inserting a guide wire through the safe zone catheter, a step oftaking out the safe zone catheter with the guide wire maintained at theposition, and a step of capturing the intervention wire using thecapture catheter inserted along the guide wire.

When the safe zone catheter and the capture catheter are integrated inone unit, that is, when it is a catheter having a blocking member at theupper and a capturing unit under the blocking member, the step ii), inmore detail, includes a step of inserting the catheter inserted in theinferior vena cava into the right ventricle through the right atrium andthe safe zone of the tricuspid valve and a step of capturing theintervention wire using the capturing unit of the catheter.

That is, the step ii) of the present invention may be a step of pullingout (guiding) the intervention wire inserted in the right ventricle inthe step i) toward the inferior vena cava using the catheter insertedthrough the inferior vena cava.

The “safe zone catheter” inserted through the vena cava is supposed tosafely pass through the “safe zone” in the heart, that is, the “safezone catheter” means a catheter that safely passes through the safe zonewithout injuring the heart after being inserted from the inferior venacava.

The catheters or the wire inserted through the inferior vena cava shouldnot injure the structures in the heart. That is, the catheters and thewires should be inserted into a round space surrounded by the subvavularstructure such as the leaflet of the tricuspid valve, the chordae of thetricuspid valve, and the papillary, and a moderator band. The virtualround space is called a “safe zone”. In order to discriminate this spacefrom a safe zone, it is called an unsafe zone, which means a space thatis not safe whereby the human body (heart) can be injured.

FIGS. 10 and 11 are anatomical pictures showing actual examples of asafe zone and an unsafe zone that a guide wire of the present inventionpasses through.

In FIGS. 10 and 11, a safe zone and an unsafe zone are clearlydiscriminated. When a wire or a catheter passes through the unsafe zone,the heart tissues may be seriously injured, so the wire or the cathetershould pass through the safe zone. Accordingly, it is required to makesure that a catheter or a wire that is inserted through the inferiorvena cava can pass through the safe zone, that is, a catheter or a wirepasses through the safe zone.

The catheter that is inserted through the inferior vena cava is called a“safe zone catheter” in terms that it is a catheter for checking whethera wire passes through a safe zone, that is, for safely passing a wirethrough a safe zone in order to pass the wire through the safe zone inthe heart.

The safe zone catheter has a blocking member at the end. The blockingmember is a member that locks the catheter when passing through anunsafe zone of the tricuspid valve, but allows the catheter to freelypass through a safe zone of the tricuspid valve so that the catheter cansafely pass through the safe zone that does not injure the tricuspidvalve. That is, the safe zone catheter can pass through only the safezone, not the unsafe zone, by the blocking member.

The blocking member may be in the shape of a balloon or a pig tail.

FIG. 12 shows an example of a safe zone catheter having a balloon andFIG. 13 shows an example of a safe zone catheter having a pigtail-shaped blocking member.

The safe zone catheter having a balloon at the end is inserted throughan inferior vena cava and then the balloon is inflated by injecting airfrom the outside, whereby it can pass through only a safe zone and notan unsafe zone. In other words, when the balloon is inserted into anunsafe zone, it cannot be further moved forward into the heart. That is,when the balloon cannot be easily moved forward, it is pulled out andthen moved forward until it can pass through a pulmonary artery througha safe zone, so the catheter can safely pass through the safe zone. Thismethod is used in the same way when the blocking member has the shape ofa pig tail.

A guide wire is inserted into the right ventricle along the safe zonecatheter. That is, a hole is formed in the safe zone catheter, so theguide wire is inserted through the hole.

The term ‘guide wire’ is given because it is a wire that is inserted toguide a capture catheter. The guide wire should safely pass through thesafe zone between the right atrium and the right ventricle. That is,when the safe zone catheter is positioned in the right ventricle throughthe safe zone, a guide wire is inserted through the hole in the safezone catheter. The guide wire would be preferably inserted up to thepulmonary artery. When the guide wire is inserted up to the pulmonaryartery, the safe zone catheter is taken out and a capture catheter thatcan capture a intervention wire in the right ventricle is inserted alongthe guide wire through the hole.

The term “capture catheter” means a catheter for capturing aintervention wire in the right ventricle and may be called a “wireguidance device” in tams that it guides a intervention wire to theinferior vena cava. Since a hole is formed in the capture catheter, thecapture catheter is inserted into the right ventricle along the guidewire through the hole.

FIG. 14 is a view illustrating a process of capturing a interventionwire using a mesh of a capture catheter of the present invention.

The mesh is contracted before it is inserted into the right ventricleand is expanded in the right ventricle, and a intervention wire is putinto the mesh and then captured by contracting the mesh. That is, themesh is expanded or contracted by operation from the outside and shouldhave a size such that a intervention wire can be easily passed thoughwhen it is expanded and a intervention wire can be held tight when it iscontracted. When a intervention wire passes through the mesh, the meshis contracted by an operation unit outside. Then, the intervention wireis captured in the mesh.

Referring to FIG. 14, (a) shows a state when a capture catheter isinserted in the right ventricle, (b) shows a state when a mesh that is acapture catheter is expanded in the right ventricle, and (c) shows astate when a intervention wire that has passed through aninterventricular septum has passed through a mesh. (d) and (c) show thesame state, (e) shows a state when the intervention wire has beencaptured by contracting the mesh, and (f) shows a state when thecaptured intervention wire is guided to the inferior vena cava by movingdown the mesh to the inferior vena cava.

It would be possible to check whether a intervention wire has passedthrough a mesh using existing displays. FIG. 15 is a view showinganother example of a mesh that is disposed at an end of a capturecatheter of the present invention. Preferably, as shown in FIG. 15, itwould be possible to easily check it through a display by forming aradiopaque marker at the upper end or the lower end of a mesh.

The safe zone catheter and the capture catheter described above may beintegrated in one surgical catheter. That is, a blocking member forpassing through a safe zone may be formed at the front (upper) end and acapturing unit for capturing a intervention wire may be formed at thelower end.

FIG. 16 is a view showing another example of a surgical catheter of thepreset invention, in which a balloon is formed at the front (top) endand a mesh is formed under the balloon.

A blocking member for safe passing through a safe zone is formed at theupper end and a capturing unit (mesh) for capturing a intervention wireis formed at the lower end.

Though not shown, a safe zone catheter and a capture catheter may beinserted in one outer catheter. The integrated (safe zone+capture)catheter described above has a blocking member for passing through asafe zone at the front end and a capturing unit for capturing anintention wire at the lower end, but a separate safe zone catheter and aseparate capture catheter may be inserted in one outer catheter.

FIG. 17 is a picture showing a capture catheter having a D-shaped meshas another example of a capture catheter for an operation of the presentinvention, in which (a) shows the state before the mesh expands and (b)shows the state after the mesh expands.

Referring to FIG. 17, the capture catheter is composed of an outercatheter, a central lumen catheter, and a mesh. In the mesh, the upperportion is closed and fixed to the central lumen catheter, and the lowerportion is closed and fixed to the outer catheter.

A hole that a guide wire passes through is formed in the central lumencatheter. This is for guiding the capture catheter so that the capturecatheter can be inserted into the right ventricle along a guide wire.The central lumen catheter can be inserted and moved up and down in theouter catheter.

In the capture catheter that is positioned in the right ventriclethrough a safe zone along a guide wire, when the outer catheter ispushed up by force from the outside of the body, the outer catheter willbe moved up along the central lumen catheter and the mesh is expanded.

It is preferable that the mesh has a D-shaped structure when expanding.This will help when it is required to guide a wire particularly to theRVOT (right ventricular outflow tract) of the right ventricle,considering the structure of the right ventricle. That is, the D-shapedmesh expands wide toward the interventricular septum close to the RVOT,so a intervention wire can be more easily inserted through the mesh.

Referring to the figures, one or more connectors for coupling a firstside of the mesh and the central lumen catheter to each other are formedso that the mesh has a D-shaped structure when expanding in the presentinvention. The connector is not fixed to the central lumen catheter, butmoved up and down along the central lumen catheter, so when the meshexpands and contracts, the connector moves up and down along the centrallumen catheter, whereby a second side of the mesh expands. The connectorkeeps holding the first side of the mesh, so when the mesh expands, thesecond side of the mesh expands wider, thereby making a D-shape.

Next, iii) the step (S30) of pulling out the intervention wire capturedby the catheter toward the inferior vena cava by pulling out thecatheter toward the inferior vena cava is performed.

When the capture catheter is pulled out toward the inferior vena cavawith the intervention wire captured by the capture catheter, theintervention wire is also taken out toward the inferior vena cava. Thecapture catheter is fully pulled out of the body, whereby theintervention wire is also pulled out of the body.

Accordingly, in the intervention wire, one end is positioned outsideover the body and the other end is positioned outside under the bodythrough the superior vena cava, the coronary sinus, the interventricularseptum, the right ventricle, the right atrium, and the inferior venacava. Accordingly, the intervention wire generally makes an a-shapedloop.

Finally, iv) the step of positioning the tip of a lead in theinterventricular septum by holding both ends of the intervention wireand inserting the lead of the pacemaker along the intervention wire isperformed.

A hole (inner hole) is formed in the pacemaker lead so that aintervention wire can be inserted therein. The upper end and the lowerend of the intervention wire protrude outside the body, so a surgeonholds both ends, passes the pacemaker lead through the inferior venacava and the coronary sinus along the intervention wire through thehole, and then positions the lead in the interventricular septum.

The surgeon inserts the pacemaker lead while holding both ends of theintervention wire, thereby securing a sufficient support force thatallows the tip of the pacemaker lead to be safely inserted into theinterventricular septum tissues.

Preferably, the tip of the pacemaker lead is pointed to easily penetratethe interventricular septum tissues and has a blocking stop (a hook) notto be easily separated after being inserted in the interventricularseptum tissues.

As described above, according to the present invention, since it ispossible to directly and effectively apply electrical stimulus to theconduction system of the heart by positioning the tip of a pacemakerlead in the interventricular septum tissues, it is possible to obtainnarrower QRS. Further, a intervention wire functions as a support, so itis possible to stably and simply insert the lead of a pacemaker into theinterventricular septum tissues.

Embodiment

The inventor(s) performed a test of positioning the tip of a pacemakerlead in the interventricular septum using the heart of a pig. The pigused in the test was a female weighing about 50 kg.

The lead of the pacemaker was Boston scientific 4Fr ACUITY™ spiral Leftventricle (LV) lead.

The test was carried out in the same way as that described above.

FIG. 5 is a picture of a pressurized septal venogram when a coronarysinus was blocked by a balloon catheter in the test and FIG. 18 is apicture when the mesh of a capture catheter captures a intervention wirepassing through an interventricular septum in accordance with anembodiment of the present invention.

In order to compare Trans-coronary sinus intraseptal pacing of thepresent invention with the RVAP of the related art, the RVAP of therelated art was performed after the test of the present invention wasperformed.

FIG. 19A is a picture showing a tip of a pacemaker lead inserted intissues of an interventricular septum in accordance with an embodimentof the present invention and FIG. 19B is a picture showing a pacemakerlead according to Trans-coronary sinus intraseptal pacing of the presentinvention and a pacemaker lead positioned at an RV apex according to anRVAP of the related art.

QRS intervals according to electrical stimulus positions in the testperformed on a pig heart are shown in FIG. 20.

FIG. 20(A) shows natural QRS fluctuations in a pig used in the test,FIG. 20(B) shows QRS fluctuation according to Intra-septal pacingaccording to the present invention, and FIG. 20(C) shows QRSfluctuations according to RVAP of the related art.

The normal QRA (self-rhythm) of the pig's heart was 62 ms and the QRS(RV apical rhythm) in the RVAP of the related art was 95 ms, but the QRSin the Intra-septal pacing rhythm according to the present invention was79 ms, so a considerably improved narrow QRS could be obtained.

Accordingly, the side effect causing a loss of ventricular function dueto ventricular desynchronization was remarkably removed by overcoming awide QRS that is a defect of the RVAP of the related art.

The above description is an example that explains the spirit of thepresent invention and may be changed and modified in various wayswithout departing from the basic features of the present invention bythose skilled in the art. Accordingly, the embodiment described hereinare provided not to limit, but to explain the spirit of the presentinvention and the spirit and the scope of the present invention are notlimited by the embodiments. The protective range of the presentdisclosure should be construed on the basis of claims and all thetechnical spirits in the equivalent range should be construed as beingincluded in the scope of the right of the present disclosure.

INDUSTRIAL APPLICABILITY

The present invention relates to a method, an apparatus, and a catheterfor positioning a terminal end of a pacemaker lead that has passedthrough coronary sinus into an interventricular septum. Accordingly, thepresent invention can be applied to a method, an apparatus, and acatheter for positioning a terminal end of a pacemaker that has passedthrough a coronary sinus into an interventricular septum in order tomore effectively transmit electrical stimulation in a treatment using apacemaker for patients with arrhythmia.

1-49. (canceled)
 50. A method of positioning a tip of a pacemaker lead,which has passed through a coronary sinus, into an interventricularseptum where a conduction system of a heart is positioned, in order toeffectively transmit electrical stimulus, the method comprising: a stepof positioning an intervention wire inserted through a superior venacava and a coronary sinus into a right ventricle of a heart through aninterventricular septum; a step of inserting a safe zone catheterinserted in an inferior vena cava into the right ventricle through aright atrium and a safe zone of a tricuspid valve; a step of inserting aguide wire through the safe zone catheter; a step of pulling out thesafe zone catheter with the guide wire maintained therein; a step ofcapturing the intervention wire with a capture catheter inserted alongthe guide wire; a step of pulling out the intervention wire captured bythe capture catheter toward the inferior vena cava by pulling out thecapture catheter toward the inferior vena cava; and a step of holdingboth ends of the intervention wire and positioning the tip of the leadinto the interventricular septum by inserting the pacemaker lead alongthe intervention wire.
 51. The method of claim 50, wherein the step ofpositioning an intervention wire includes a step of finding a septalvein positioned in the interventricular septum by inflating a balloon ata front end of a balloon-tipped guiding catheter to block and contrastthe coronary sinus by injecting air into the balloon from the outside.52. The method of claim 50, wherein the step of positioning anintervention wire includes a step of boring that uses aninterventricular septum lumen catheter to bore the interventricularseptum. 53-54. (canceled)
 55. The method of claim 50, wherein theblocking member of the safe zone catheter is a balloon that is inflatedby air from the outside.
 56. The method of claim 50, wherein theblocking member of the safe zone catheter has a pig tail shape.
 57. Themethod of claim 50, wherein a mesh that is expanded or contracted byoperation from the outside is formed at the capture catheter.
 58. Themethod of claim 50, the capture catheter includes: a central lumencatheter having a hole therein for inserting a wire; an outer cathetermoving up and down in the central lumen catheter; and a mesh having anupper portion closed and fixed to the central lumen catheter and a lowerportion closed and fixed to the outer catheter.
 59. The method of claim50, wherein a hole for inserting the intervention wire is formed in thepacemaker lead and the tip of the pacemaker lead is pointed to easilypenetrate the interventricular septum tissues.
 60. A method ofpositioning a tip of a pacemaker lead, which has passed through acoronary sinus, into an interventricular septum where a conductionsystem of a heart is positioned, in order to effectively transmitelectrical stimulus, the method comprising: positioning an interventionwire inserted through a superior vena cava and a coronary sinus into aright ventricle of a heart through an interventricular septum; insertinga catheter inserted in an inferior vena cava into the right ventriclethrough a right atrium and a safe zone of a tricuspid valve and thencapturing the intervention wire using a capturing unit of the catheter;pulling out the catheter toward the inferior vena cava by pulling outthe intervention wire captured by the catheter toward the interior venacava; and positioning the tip of the lead into the interventricularseptum by holding both ends of the intervention wire and inserting thelead of the pacemaker along the intervention wire.
 61. The method ofclaim 60, wherein the step of positioning an intervention wire includesa step of finding a septal vein positioned in the interventricularseptum by inflating a balloon at a front end of a balloon-tipped guidingcatheter to block and contrast the coronary sinus by injecting air intothe balloon from the outside.
 62. The method of claim 60, wherein thestep of positioning an intervention wire includes a step of boring thatuses an interventricular septum lumen catheter to bore theinterventricular septum. 63-66. (canceled)
 67. The method of claim 60,wherein a mesh that is expanded or contracted by operation from theoutside is formed at the capturing unit.
 68. The method of claim 60, thecapture catheter includes: a central lumen catheter having a holetherein for inserting a wire; an outer catheter moving up and down inthe central lumen catheter; and a mesh having an upper portion closedand fixed to the central lumen catheter and a lower portion closed andfixed to the outer catheter.
 69. The method of claim 60, wherein a holefor inserting the intervention wire is formed in the pacemaker lead andthe tip of the pacemaker lead is pointed to easily penetrate theinterventricular septum tissues.
 70. A method of positioning a tip of apacemaker lead, which has passed through a coronary sinus, into aninterventricular septum, in order to effectively transmit electricalstimulus, the method comprising: a step of inserting into anintervention wire through a superior vena cava and a coronary sinus topass through the interventricular septum and then guiding theintervention wire to an inferior vena cava; and a step of positioningthe tip of the lead into the interventricular septum by inserting thepacemaker lead along the intervention wire.